Class 2 Device Recall ENDOSCOPE REPROCESSOR OERPRO MODEL OERPRO

• Date Initiated by Firm: July 12, 2023
• Date Posted: August 23, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2447-2023
• Recall Event ID: 92728
• 510(K)Number: K103264
• Product Classification: Accessories, cleaning, for endoscope - Product Code FEB
• Product: The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5
• Code Information: UDI-DI: 04953170355929. All lot numbers
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: SAME; 484-896-5000
• Manufacturer Reason for Recall: The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.
• FDA Determined Cause: Under Investigation by firm
• Action: Olympus issued Urgent Medical Device Field Corrective Action letter on July 12,2023. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory for the referenced devices and identify any device with the model names specified above. Please check all areas of the hospital and include a copy of this letter and addendum with any of these devices remaining in inventory. 2. Carefully read the content of this Medical Device Field Corrective Action as well as the attached Addendum for valve inspection instructions and updated MAJ-1444 reprocessing instructions: Disinfect the MAJ-1444 in the OER by placing the MAJ-1444 individually in the washing case of the endoscope reprocessor, with no other accessories. Note: Steam sterilization (autoclaving) or manual high-level disinfection remain available options per the existing instruction for use. 3. Ensure all personnel are informed on valve inspection requirements and to cease use and dispose of any valves suspected of having an abnormality. 4. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the file (recall) number: 0428 5. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. Actions to be taken by the company: Olympus is updating the MAJ-1444 Instructions for Use to reflect the information found in the attached addendum. MAJ-1444 valves will be shipped with the Addendum until the Instructions for Use are updated. Olympus requests that you report complaints, including any injuries associated with the use of MAJ-1444, to our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). For additional support concerning this matter, please contact Tara Safi, Field Corrective Actions Administrator, at Tara.Safi@Olympus.com.
• Quantity in Commerce: 29590 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FEB